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www.fdanews.com/articles/159776-fda-already-has-postmarket-plans-for-janssens-hep-c-candidate-simeprevir

FDA Already Has Postmarket Plans for Janssen’s Hep C Candidate Simeprevir

October 24, 2013
Janssen’s hepatitis C virus (HCV) therapy simeprevir is efficacious and has a “generally acceptable” safety profile, FDA briefing documents posted Tuesday state. Agency reviewers offer postmarket fixes for what would be the third HCV protease inhibitor approved in the U.S.
Drug Industry Daily